Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 5-13, and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Double Patenting
Claims 1 and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of copending Application No. 17655937 in view of WEBER et al.( WO 2019222091) hereinafter WEBER et al.
Regarding claims 1 and 15, copending Application No. 17655937 teaches the subject matter of claim 1 and 15 but does not teach the electronic control system configured to control the at least one valve in response to the received pressure so as to control a fluid flow rate within the inflatable device.
WEBER et al. teaches an inflatable penile prosthesis (100) includes a fluid reservoir (102) configured to hold fluid, an inflatable member (104), and a pump assembly (106) configured to transfer the fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes a first pump (108) configured to inject the fluid into the inflatable member according to a first flow rate, and a second pump (110) configured to inject fluid into the inflatable member according to a second flow rate, where the second flow rate is less than the first flow rate.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in copending Application No. the electronic control system configured to control the at least one valve in
response to the received pressure so as to control a fluid flow rate within the inflatable device as taught by WEBER et al. to better control the fluid and pressure within the implanted system.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WEBER et al.( WO 2019222091) hereinafter WEBER et al.
WEBER et al. teaches an inflatable penile prosthesis (100) includes a fluid reservoir (102) configured to hold fluid, an inflatable member (104), and a pump assembly (106) configured to transfer the fluid from the fluid reservoir to the inflatable member during an inflation cycle. The pump assembly includes a first pump (108) configured to inject the fluid into the inflatable member according to a first flow rate, and a second pump (110) configured to inject fluid into the inflatable member according to a second flow rate, where the second flow rate is less than the first flow rate.
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Regarding claims 1 and 15, WEBER et al. teaches a fluid reservoir; an inflatable member; a fluid control system configured to transfer fluid between the fluid reservoir and the inflatable member, including: a housing; at least one valve and at least one pump positioned in a fluid passageway within in the housing; a first fluid port in fluidic communication with the fluid reservoir; and a second fluid port in fluidic communication with the inflatable member; at least one pressure sensing device configured to sense a fluid pressure in the implantable fluid operated inflatable device; and an electronic control system configured to receive the pressure sensed by the at least one pressure sensing device, and to control the at least one valve and-at least one pump in response to the received pressure, the electronic control system configured to control the at least one valve in response to the received pressure so as to control a fluid flow rate within the inflatable device.
Note annotated figure 4A above and paragraph [0055] The pump assembly 406 includes a plurality of valves such as a valve 430, a valve 432, and a valve 434, which are disposed within fluid passageways of the valve block or body of the pump assembly 406.
Note paragraph [0055] teaches the body of the pump assembly which is interpreted as a housing for the pump/pump assembly.
Note [0045] In some examples, the controller 112 is configured to control one or more valves to transition the first pump 108 and the second pump 110 between a parallel configuration and a serial configuration during different phases of the inflation cycle. The valves may be disposed in fluid passageways within a valve body or block of the pump assembly 106 and note paragraph [0055].
Note paragraph [0055] Each of the valve 430, the valve 432, and the valve 434 includes a first port and a second port. In the closed position, fluid does not transfer between the first port and the second port. In the open position, fluid is permitted to transfer between the first port and the second.
Note paragraphs [0029] the multiple pumps are not individually controlled by the user, but are mechanically and/or programmatically controlled by a controller 112 , [0040]- [0049] , [0042] the sensor 115 is configured to sense the pressure level in the inflatable member 104 and send one or more signals to the controller 112 that indicate the pressure level in the inflatable member 104. In some examples, the sensor 115 is configured to monitor the flowrate (e.g., the flowrate in both directions). The controller 112 may control the activation (and deactivation) of the first pump 108 and the second pump 110 based on the signals received from the sensor 115.
Note paragraph [0042] In some examples, the sensor 115 is configured to sense the pressure level in the inflatable member 104 and send one or more signals to the controller 112 that indicate the pressure level in the inflatable member 104. In some examples, the sensor 115 is configured to monitor the flowrate (e.g., the flowrate in both directions). The controller 112 may control the activation (and deactivation) of the first pump 108 and the second pump 110 based on the signals received from the sensor 115.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 5-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WEBER et al.( WO 2019222091) hereinafter WEBER et al. in view of Allen(US 4903732) hereinafter Allen.
Regarding claim 5 WEBER et al. teaches [0045] In some examples, the controller 112 is configured to control one or more valves to transition the first pump 108 and the second pump 110 between a parallel configuration and a serial configuration during different phases of the inflation cycle. The controller 112 is configured to actuate one or more valves (e.g., place the valves in either an open position where fluid can flow through a valve or a closed position in which fluid is blocked) to arrange the first pump 108 and the second pump 110 in the parallel configuration. Note also paragraph [0055].
WEBER et al. does not specifically teach where the valve is a piezoelectric valve with a diaphragm.
Allen teaches A piezoelectric valve for controlling fluid flow through valve ports comprises a fluid tight valve body and a diaphragm. The valve body defines valve ports, and the diaphragm includes a plurality of piezoelectric members, the members being adapted to be selectively piezoelectrically deflected in opposite directions in a plane of operation thereof to produce a cumulative excursion to selectively block or unblock the valve ports. The enhanced cumulative excursion enables valve ports of greater cross-sectional area to be employed. [12] Electrical means are operatively connected to the members for piezoelectrically deflecting the same. Preferably the members are adapted to be selectively piezoelectrically deflected between a first orientation wherein the members are bowed apart and a second orientation wherein the members are generally parallel, the members assuming the first orientation when the electrical means are energized to piezoelectrically deflect the members and the second orientation when the electrical means are de-energized so said members are not piezoelectrically deflected. The members may be substantially planar when not piezoelectrically deflected and substantially curved when piezoelectrically deflected.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of WEBER et al. a piezoelectric diaphragm valve as taught by Allen as substitution of one known valve for another. The use of various passive and active electromechanical valves are known in view of Smith et al and piezoelectric diaphragm valves are known as evidenced by Allen and the substitution of one known valve for another would achieve predictable results and yield a functioning fluid controlled device.
Regarding claim 6, WEBER et al. in view of Allen teaches wherein the variable voltage applied to the piezoelectric element to maintain the set state of the fluid operated inflatable device is based on the pressure detected in the fluid passageway of the valve relative to an atmospheric pressure sensed by the electronic control system.
Weber et al. teaches monitoring the pressure within the fluid passageways and the inflatable members and controlling the pumps and valves if the pressure exceeds a threshold and adjusting the flow rate. Any established threshold would be relative to atmospheric pressure.
Allen teaches varying the voltage of the piezoelectric valves to open and control the valves as part of the operation of the valves.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include and operate use the piezoelectric valves in the device of weber et al. as taught by Allen by varying the voltage applied to the diaphragm based on the measure pressure.
Regarding claim 7, , WEBER et al. in view of Allen teaches wherein the variable voltage applied to the piezoelectric element adjusts a position of the piezoelectric element and the diaphragm to adjust for atmospheric conditions and correspond to the set state of the fluid- controlled inflatable device.
Weber et al. teaches monitoring the pressure within the fluid passageways and the inflatable members and controlling the pumps and valves if the pressure exceeds a threshold and adjusting the flow rate. Any established threshold would be relative to atmospheric pressure.
Allen teaches varying the voltage of the piezoelectric valves to open and control the valves as part of the operation of the valves.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include and operate use the piezoelectric valves in the device of weber et al. as taught by Allen by varying the voltage applied to the diaphragm based on the measure pressure.
Regarding claim 10, Weber et al. teaches wherein the normally open piezoelectric valve is configured to remain in the closed state for a period of time after release of the voltage, and to transition to the normally open state in response to dissipation of electrical bias accumulated in the piezoelectric element. Note paragraph [0045], The controller 112 is configured to actuate one or more valves (e.g., place the valves in either an open position where fluid can flow through a valve or a closed position in which fluid is blocked) to arrange the first pump 108 and the second pump 110 in the parallel configuration. Note also paragraph [0055].
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over by WEBER et al.( WO 2019222091) hereinafter WEBER et al. in view of Allen(US 4903732) hereinafter Allen and further in view of Birk(US 8905915) hereinafter Birk.
Regarding claims 8-9, WEBER et al. as modified by Allen does not specifically teach wherein the voltage applied to the piezoelectric element is selected from a calibration curve associated with the piezoelectric valve that is accessible in a memory of the electronic control system.
Birk teaches a self-regulating gastric band apparatus for adjusting stoma size is disclosed. The apparatus includes an adjustable gastric band that has an expandable portion containing a volume of fluid. A band adjustment assembly is provided for implanting with the gastric band that includes a sensor for sensing fluid pressure in the expandable portion. The band adjustment assembly further includes a pump assembly connected to the expandable portion and to a controller that operates the pump assembly to adjust the volume of the fluid in the band based on the sensed fluid pressure. The band adjustment assembly includes memory storing an operating range relative to a target fluid pressure, and the pump assembly is operated to maintain the sensed band pressure within the operating range. The target pressure is set to maintain pressure variations below a predefined variation limit generally corresponding with satiated fill volumes for a particular patient and implanted band.
Although Birk does not specifically set forth a calibration curve of the valve to set the pressure, It is noted that there are a limited number of choices available to a person of ordinary skill in the art for adjusting and the pressure and applying a voltage or power to the pump and or valves to create the desired open or closed state.
WEBER et al. as modified by Allen recognizes the need to adjust the voltage based on the pressure readings and to achieve a designated target threshold and Birk teaches memory storing an operating range relative to a target fluid pressure, and the pump assembly is operated to maintain the sensed band pressure within the operating range. Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Smith et al. as modified by Allen a memory storing operational parameters of the valves to adjust the voltage applied to the pump and valves to achieve the desired pressure within the system. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable WEBER et al.( WO 2019222091) hereinafter WEBER et al. in view of Allen(US 4903732) hereinafter Allen and further in view of Shachar (US 20040078027) hereinafter Shachar.
WEBER et al. as modified by Allen does not specifically teach the normally open piezoelectric valve further comprising a resistor electrically connected to the piezoelectric element, wherein the resistor is configured to control a dissipation of electrical bias accumulated in the piezoelectric element such that the normally open piezoelectric valve transitions from the closed state to the normally open state in a set period of time after release of the voltage.
Shachar teaches a method and apparatus for a localized implant for infusion of a variety of biological response modifiers (BRMs) and chemotherapeutic agents including tumor necrosis factors (TNF) is described. an electronic system provides tailored and controlled regulation of the administration of such agents, using sensors to monitor the progress of the treatment. Desired dosing and scheduling of anti-tumor agents in a local setting is provided. Active control and regulation of the administration of medicating agents is attached to a synthetic pouch and with the aid of a piezoelectric valve and pump actuating mechanism. [0063] FIG. 4 shows the three drivers for the three piezo electric valves. In the figure the drivers are made of an NPN transistor, 411, such as the National Semiconductor 2N3906, whose input is derived from the microcontroller 401. The signal from the microcontroller 401 is fed to the NPN transistor 411 through a base resistor 463. An additional resistor 462 is placed in the collector of the transistor 411. The piezoelectric valve 412 is placed in parallel to the collector resistor 462. [0064] Resistor 463 is a base current limiter and resistor 462 is the collector resistor for transistor 411, which allows for fast discharge of charge build-up across the piezo-electric device 412.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of WEBER et al. as modified by Allen a resistor in the piezoelectric resistor circuit as taught by Shachar for fast discharge of charge across the piezoelectric device. Furthermore, It is noted that there are a limited number of choices available to a person of ordinary skill in the art for constructing the piezoelectric circuits for proper operation and utilizing a resistor is one of the finite number of methods for managing excess charge in a piezoelectric device as evidenced by Schachar with a reasonable expectation of successfully using the piezoelectric valve to open and close and control fluid flow within the implanted system. See KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over WEBER et al.( WO 2019222091) hereinafter WEBER et al. in view of Allen(US 4903732) hereinafter Allen and further in view of Birk(US 8905915) hereinafter Birk and further in view of Ben-Ami (WO 2012127420) hereinafter Ben-Ami.
WEBER et al. as modified by Allen and Birk does teach wherein the piezoelectric valve is a normally closed piezoelectric valve that is configured to transition from a normally closed state to an open state in response to an application of voltage to the piezoelectric element, and to return to the normally closed state in response to release of the voltage
However, WEBER et al. as modified by Allen and Birk does not teach the normally closed piezoelectric valve including: a plunger movably positioned within the fluid passageway of the normally closed piezoelectric valve, wherein the plunger is sealed against the valve base in the normally closed state so as to restrict flow through the fluid passageway, and is spaced apart from the valve base in the open state so as to open the fluid passageway. in the normally closed state of the normally closed piezoelectric valve, a backpressure applied to the plunger through the at least one outlet maintains the sealed position of the plunger against the valve base in response to a surge in fluid pressure at the at least one inlet.
Ben-Ami teaches implantable prosthetic valve assembly comprises a piezoelectric actuator (102), a valve plunger or skirt, a sensor module, a valve actuating assembly (100), and a housing. The piezoelectric actuator fits with a valve regulator (104) that is controlled with an actuator power and a control module. The valve regulator: is displaced about an actuator shaft to regulate a flow through a passageway; and provides for a flow control through the passageway by manipulating the valve plunger or skirt and provides for controlling a position of the valve skirt or plunger.
It is noted that there are a limited number of choices available to a person of ordinary skill in the art for piezoelectric valve control of fluid flow. Piezoelectric valves are well known in the art as evidenced by WEBER et al. as modified by Allen and Birk and a plunger controlled piezoelectric valve is well known as evidenced by Ben-Ami. One of ordinary skill in the art would have found it an obvious simple substitution of one known element for another to obtain predictable results to substitute the piezoelectric valve of Smith et al. as modified by Allen and Birk for the plunger controlled piezoelectric valve of ben-Ami with a reasonable expectation of successfully controlling the flow of fluid within the inflatable implant. Furthermore, the Smith et al. as modified by Allen and Birk and Ben-Ami is capable of functioning to manage a backpressure applied to the plunger as part of its normal operation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
NEWMAN et al.( US 20170079760) teaches an implantable module in wireless communication is provided with the external controller. The implantable modules have a fluid reservoir, flexible circuit board, and pressure and rpm sensors. The flexible circuit board (404) is located within the fluid reservoir. An inflatable medical implant (417) is connected to the fluid reservoir through flexible tubing and is inflated by fluid which is transferred from the fluid reservoir through the tubing using pump (411).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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